Travel Requirements: This position may require up to 25% travel
Application Period: Friday, June 10, 2022, through Thursday, June 30, 2022
Salary Range: $106,823.00 - $164,102.00 (commensurate with education and experience)
Position Information: Full-Time – Appointment term of two (2) years, with possibility of being extended
Who may be considered: U.S. Citizens; Permanent Residents; and Non-Citizens
Introduction: The Center for Devices and Radiological Health (CDRH or Center) assures that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. CDRH facilitates medical device innovation by advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and assuring consumer confidence in devices marketed in the U.S. The Office of Strategic Partnerships and Technology Innovation (OST or Office) provides leadership for all scientific, collaborative, and emerging technology related activities at the Center. Additionally, this Office is charged with strengthening public health supply chains by proactively monitoring, assessing, and communicating risks and vulnerabilities to prevent shortages of medical devices within the U.S. To support this mission, OST’s Resilient Supply Chain Program (RSCP or Program) has and continues to develop innovative and effective national strategies, in collaboration with industry, as well as public and private stakeholders, to ensure adequate inventories of safe, effective, and reliable medical devices are available and accessible for use.
Position Summary: The RSCP has immediate openings for Staff Fellows (Health Scientists). The candidates should have strong backgrounds in medical devices as well as knowledge of medical device supply chains and/or regulations. Incumbents will be responsible for supporting the Center in matters relating to the availability of medical devices and their supply chains, to include vulnerability assessment, threat mitigation management, and establishing strategic metrics and milestones centered on supply chain resiliency.
Position Title: Staff Fellow – Health Scientist: RSCP is seeking candidates well versed in medical device development, manufacturing, and the regulatory review process, as they will serve as cogent voices in the provision of sound, theoretical, and evidence-based information to ensure the sustained availability of medical devices during periods of calm and when public health threats and emergencies arise.
Candidates must be able to demonstrate mastery of principles, practices, and theories in the fields of Engineering, Epidemiology, and Data Analytics, as well as those of Supply Chain Management, which will enable the selectees to research emerging technologies to enhance data collection, improve threat analysis capabilities, and develop short-term and long-range replicable solutions to aid in the prediction and mitigation of actual and potential supply chain disruptions. Further, the selectees will support and/or lead the development of supply chain visualizations for a wide range of medical device products to identify and assess vulnerabilities, risks, alternative products, and potential mitigations. Successful candidates will work to influence policy, develop rulemaking, issues guidance, and generate written evidence-based technical and scientific recommendations to address supply chain vulnerabilities and risks, which could lead to potential disruptions.
Educational Requirements: In order to be eligible for a Staff Fellow position, applicants should possess a Ph.D. or equivalent degree. Additionally, in order to qualify for the Health Scientist series, applicants must possess a bachelor’s or graduate/higher level degree in a major course of study in an academic field related to the medical field, health sciences, or allied sciences appropriate to the work of the position. Applicants who have completed part or all their education outside the U.S. must have their foreign education evaluated by an accredited organization to ensure that the foreign education is comparable to education received in accredited educational institutions in the U.S. This evaluation must also be provided by midnight Eastern Time on the closing date of this vacancy announcement. For more information on Foreign Education verification, visit the U.S. Department of Education. Another listing of services that can perform this evaluation is available at the National Association of Credential Evaluation Services (NACES) website.
Qualifications:Knowledge, skills, and abilities relevant to each area described below, must be clearly evident within application documents:
Experience in conducting analyses of existing technologies in comparison with needed capabilities to support medical device supply chain data analytics implementation.
Demonstrated track record of establishing and integrating complex, cross-organizational processes, data governance, and information management strategies, and/or developing strategic metrics and milestones centered on supply chain resiliency.
Aptitude for integrating in-depth scientific and clinical knowledge with applicable laws, regulations, and policies to support other scientists in making regulatory decisions concerning complex medical device products and their supply chains.
Experience in supporting and/or leading inter-disciplinary teams of clinical and scientific experts to resolve scientifically challenging and complex multi-layered supply chain concerns that may impact health care delivery systems.
Experience in delivering timely analysis, solution development, and resolutions through participation on cross-cutting teams for the benefit of decision-making leadership.
Ability to represent the Office and Center at professional meetings and conferences with members of the scientific, health care, and patient advocacy communities focused on medical device use and need during supply chain disruptions and shortages.
Experience in cultivating formal and informal stakeholder partnerships.
Experience in project management and risk management.
Excellent scientific writing and communication skills
How to Apply: Submit an electronic resume or curriculum vitae, cover letter containing describing why you are uniquely qualified for this position, and a copy of unofficial transcripts all in one document (Adobe PDF) to [email protected], with Job Reference code “2022-OST-IO-Health Scientist-037T” in the subject line. Applications will be accepted through June 30, 2022.
Additional Announcement Information
COVID-19: Due to COVID-19, the Agency is currently in an expanded telework posture. If selected, you may be expected to temporarily telework, even if your home is located outside the local commuting area. Once employees are permitted to return to the office, you will be expected to report to the duty station listed on this announcement within 45 days. At that time, you may be eligible to request to continue to telework one or more days a pay period depending upon the terms of the agency's telework policy. To ensure compliance with an applicable preliminary nationwide injunction, which may be supplemented, modified, or vacated, depending on the course of ongoing litigation, the Federal Government will take no action to implement or enforce the COVID-19 vaccination requirement pursuant to Executive Order 14043 on Requiring Coronavirus Disease 2019 Vaccination for Federal Employees. Safer Federal Workforce Task Force guidance on other Federal agency safety protocols based on vaccination status—including guidance on protocols related to masking, distancing, travel, testing, and quarantine—remains in effect.
Security and Background Requirements: All candidates must meet applicable security requirements which include a background check and a minimum of 3 out of the past 5 years’ residency status in the US. If not previously completed, a background security investigation will be required for all appointees. Appointment will be subject to the applicant’s successful completion of a background security investigation and favorable adjudication. Failure to successfully meet these requirements may be grounds for appropriate personnel action. In addition, if hired, a background security reinvestigation or supplemental investigation may be required at a later time. Applicants are also advised that all information concerning qualifications is subject to investigation. False representation may be grounds for non-consideration, non-selection, or appropriate disciplinary
About U.S Food and Drug Administration, Center for Devices and Radiological Health
The mission of the Center for Devices and Radiological Health (CDRH) is to protect and promote the public health. We assure that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. We provide consumers, patients, their caregivers, and providers with understandable and accessible science-based information about the products we oversee. We facilitate medical device innovation by advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and assuring consumer confidence in devices marketed in the U.S.